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CompletedNCT06220760Updated Nov 21, 2025

Outcomes of Placenta Accreta Spectrum Disorders Surgery in Relation to Placenta Accreta Scoring Index

An observational study in Placenta Previa and Placenta Accreta, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Using of Ultra sound in assessment of Placenta Accreta Index to predict the surgical outcomes of Placenta accreta

Read the detailed description

Placenta accreta is a substantially life-threatening condition and one of the causes of maternal morbidity and mortality in the world. According to study done in United Kingdom, The estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities overall and 577 per 10,000 in women with both a previous caesarean delivery and placenta previa [1]. in a tertiary south Italian center, The incidence increased from 0.12% during the 1970s, to 0.31% during the 2000s [2].While in USA, the prevalence of placenta accreta was 3.7 per 1000 deliveries [3].

This increase is due to many factors. A scar of previous uterine surgery is a major risk factor for placenta accreta. Caesarean section scar is the most common one of uterine scars according to [4] especially in presence of placenta previa where the risk of placenta accreta was 3%, 11%, 40%, 61%, and 67% for the first, second, third, fourth, and fifth or greater repeat cesarean deliveries, respectively. [5] reported that both cesarean delivery morbidity and placenta accreta were positively associated with age >30 years. Previous myomectomy, multi parity, vigorous curettage are other risk factors as said [6]. More ever sub mucous leiomyoma and thermal ablation are also contributing factors to Placenta accreta [7] and lastly [8] said that uterine artery embolization is considered as a risk factor for occurrence of placenta accreta. Contrarily, inter pregnancy interval more than 60 months was associated with decreased risk of placenta accreta [9].

Because placenta accreta can lead to life-threatening blood loss, identification of these high-risk patients would be helpful in management of the pregnancy in addition to enabling the surgeon to be prepared adequately before the time of delivery. Many studies have been done on identification of placenta accreta in the third trimester by 2D ultrasound and color Doppler. There are many modalities for detection of placenta accreta ante natally [10] used 2D ultrasound and color doppler for detection of placenta accreta in 3rd trimester with sensitivity and specificity; 95.24% and 94.74% respectively for ultrasound with the most prominent feature presence of multiple lakes that represented dilated vessels extending from the placenta through the myometrium. For Doppler, the most prominent feature was the presence of interphase hypervascularity with abnormal vessels linking the placenta to the bladder, and the rate was 95.24%.

As for surgery for placenta accreta, planned caesarean hysterectomy is recommended to reduce mortality and morbidity, but fertility is lost. Antenatal diagnosis of placenta accreta spectrum (PAS) can ensure multidisciplinary management at center of excellence which can reduce maternal and fetal complications. This can be established by a scoring system which provides a standardized criterion for the diagnosis and management Placenta Accreta Index (PAI).

Instead of adhering to the conventional approach that involves an elective caesarean hysterectomy based on antenatal imaging, more suitable approaches should be considered from the spectrum of hemostatic and fertility-preserving options available. In our study we will investigate if the degree of adherence is related to the PAI score. Therefore, we can predict cases which will need conservative surgery or peripartum hysterectomy. And so that the surgeon be preplanned to do either hysterectomy or conservative surgery

02

Conditions studied

  • Placenta Previa
  • Placenta Accreta
03

In context

Placenta Previa

80 studies on the registry are indexed under Placenta Previa; 17 are open to participants now.

This study's enrollment of 154 is above the median of 100 across 32 observational studies indexed under Placenta Previa.

Browse Placenta Previa studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with Previous Scar of cesarean section who are 32weeks of gestation or more who are known to be Placenta previa

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. pregnant women with gestational age 32 weeks or more
  2. singleton pregnancy
  3. known to have placenta previa (lower edge of the placenta within 5 cm from internal Os )
  4. with at least previous 1 cesarean section

Exclusion criteria

Exclusion Criteria:

  1. the patient is active in labor
  2. haemodynamically unstable
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testUltrasound

    The use of US to calculate placenta accreta index

06

What researchers measure

Primary outcomes

  1. to decide If placenta accreta index (PAI) can predict suitable type of operation needed whether Conservative management/fertility-sparing techniques or Caesarean hysterectomy

    Time frame: 23 months

Secondary outcomes

  1. Incidence of fetal complication associated with placenta accreta

    Time frame: 23 months

  2. Incidence of maternal complications associated with placenta accreta

    Time frame: 23 months

  3. The need for ICU admission after placenta accreta surgery and its duration

    Time frame: 23 months

07

Study locations

1 site
  • Assiut University
    Asyut, Asyut Governorate 71515, Egypt
08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06220760
Lead sponsor
Assiut University
Responsible party
Mohammed Nagy Zaki (Clinical professor, Assiut University) — Principal investigator
First posted
Jan 24, 2024
Start date
Feb 20, 2024
Primary completion
Dec 30, 2024
Completion
Sep 30, 2025
Last update
Nov 21, 2025

Study contacts

Mohammed Nagy, MD
study chair · Assiut University
Mansour Khalifa, MD
study director · Assiut University
Mostafa Hussien, MD
principal investigator · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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